Stimulation Apparatus

This application is a continuation of U.S. patent application Ser. No. 17/379,928, filed Jul. 19, 2021, which is a continuation of U.S. patent application Ser. No. 16/672,921, filed Nov. 4, 2019, now U.S. Pat. No. 11,097,096; which is a continuation of PCT Application No. PCT/US18/31904, filed May 9, 2018; which claims priority to U.S. Provisional Patent Application Ser. No. 62/503,772, filed on May 9, 2017; U.S. Provisional Patent Application Ser. No. 62/555,557, filed on Sep. 7, 2017; and U.S. Provisional Patent Application Ser. No. 62/652,449, filed on Apr. 4, 2018; the entire disclosures of which are incorporated herein by reference in their entirety for all purposes.

This application is related to: U.S. patent application Ser. No. 14/424,303, titled “Wireless Implantable Sensing Devices”, filed Feb. 26, 2015, now Abandoned; U.S. patent application Ser. No. 14/975,358, titled “Method and Apparatus for Minimally Invasive Implantable Modulators”, filed Dec. 18, 2015; U.S. patent application Ser. No. 15/264,864, titled “Method and Apparatus for Versatile Minimally Invasive Neuromodulators”, filed Sep. 14, 2016, now U.S. Pat. No. 10,238,872; U.S. patent application Ser. No. 15/385,729, titled “Method and Apparatus for Neuromodulation Treatments of Pain and Other Conditions”, filed Dec. 20, 2016, now U.S. Pat. No. 10,335,596; International PCT Patent Application Serial Number PCT/US2016/016888, titled “Medical Apparatus Including an Implantable System and an External System”, filed Feb. 5, 2016; International PCT Patent Application Serial Number PCT/US2016/051177, titled “Apparatus for Peripheral or Spinal Stimulation”, filed Sep. 9, 2016; International PCT Patent Application Serial Number PCT/US2017/017978, titled “Apparatus with Enhanced Stimulation Waveforms”, filed Feb. 15, 2017; International PCT Patent Application Serial Number PCT/US2017/023400, titled “Devices and Methods for Positioning External Devices in Relation to Implanted Devices”, filed Mar. 21, 2017; U.S. Provisional Patent Application Ser. No. 62/341,418, titled “Methods and Systems for Insertion and Fixation of Implantable Devices”, filed May 25, 2016; U.S. Provisional Patent Application Ser. No. 62/363,742, titled “Methods and Systems for Treating Pelvic Disorders and Pain Conditions”, filed Jul. 18, 2016; U.S. Provisional Patent Application Ser. No. 62/441,056, titled “Stimulation Apparatus”, filed Dec. 30, 2016; U.S. Provisional Patent Application Ser. No. 62/463,328, titled “Apparatus with Sequentially Implanted Stimulators”, filed Feb. 24, 2017; U.S. Provisional Patent Application Ser. No. 62/503,772, titled “Stimulation Apparatus”, filed May 9, 2017; U.S. Provisional Patent Application Ser. No. 62/555,557, titled “Stimulation Apparatus”, filed Sep. 7, 2017; and U.S. Provisional Patent Application Ser. No. 62/652,449, titled “Stimulation Apparatus”, filed Apr. 4, 2018; the content of each of which is incorporated herein by reference in its entirety for all purposes.

The present invention relates generally to medical apparatus for a patient, and in particular, apparatus that deliver enhanced stimulation to effectively deliver a therapy while avoiding undesired effects.

Implantable devices that treat a patient and/or record patient data are known. For example, implants that deliver energy such as electrical energy, or deliver agents such as pharmaceutical agents are commercially available. Implantable electrical stimulators can be used to pace or defibrillate the heart, as well as modulate nerve tissue (e.g. to treat pain). Most implants are relatively large devices with batteries and long conduits, such as implantable leads configured to deliver electrical energy or implantable tubes (i.e. catheters) to deliver an agent. These implants require a fairly invasive implantation procedure, and periodic battery replacement, which requires additional surgery. The large sizes of these devices and their high costs have prevented their use in a variety of applications.

Nerve stimulation treatments have shown increasing promise recently, showing potential in the treatment of many chronic diseases including drug-resistant hypertension, motility disorders in the intestinal system, metabolic disorders arising from diabetes and obesity, and both chronic and acute pain conditions among others. Many of these implantable device configurations have not been developed effectively because of the lack of miniaturization and power efficiency, in addition to other limitations.

There is a need for apparatus, systems, devices and methods that provide one or more implantable devices and are designed to provide enhanced treatment of pain and other enhanced benefits.

According to an aspect of the present inventive concepts, a medical apparatus for a patient comprises an external system configured to transmit one or more transmission signals, each transmission signal comprising at least power or data, an implantable system configured to receive the one or more transmission signals from the external system. The external system comprises a first external device comprising: at least one external antenna configured to transmit a first transmission signal to the implantable system, the first transmission signal comprising at least power or data; an external transmitter configured to drive the at least one external antenna; an external power supply configured to provide power to at least the external transmitter; and an external controller configured to control the external transmitter. The implantable system comprises a first implantable device comprising: at least one implantable antenna configured to receive the first transmission signal from the first external device; an implantable receiver configured to receive the first transmission signal from the at least one implantable antenna; at least one implantable stimulation element configured to deliver stimulation energy to the patient; an implantable controller configured to control the energy delivered to the at least one implantable stimulation element; an implantable energy storage assembly configured to provide power to an element selected from the group consisting of: the at least one stimulation element; the implantable controller; the implantable receiver; and combinations thereof; and an implantable housing surrounding at least the implantable controller and the implantable receiver.

In some embodiments, the apparatus further comprises an O-ring connector and housing assembly into which the O-ring connector is inserted and operably connected. The apparatus can further comprise a trialing interface which includes the O-ring connector and housing assembly. The first implantable device can comprise the O-ring connector. The O-ring connector can comprise an O-ring stack including multiple O-rings. The multiple O-rings can comprise an electrically conductive material. The O-ring stack can further comprise multiple isolating elements positioned between each O-ring, the isolating elements can be configured to electrically and/or fluidly isolate the O-rings. The O-rings can comprise an anti-microbial agent.

In some embodiments, the first implantable device comprises an electronics assembly constructed and arranged to be positioned within the implantable housing in a folded state. The electronics assembly can comprise a printed circuit board with traces and integrated circuits, and the at least one implantable antenna can be positioned away from the board traces and/or integrated circuits.

In some embodiments, the first implantable device comprises an electronics assembly including a flexible printed circuit board with multiple metal layers, and the at least one implantable antenna comprises the multiple metal layers.

In some embodiments, the at least one external antenna comprises a loop with a first diameter, and the at least one implantable antenna comprises a loop with a second diameter, and the first diameter is greater than the second diameter, and the at least one external antenna is positioned to surround the at least one implantable antenna during transmissions of data and/or power between the first external device and the first implantable device. The at least one external antenna can comprise a circular, elliptical, square, or rectangular loop.

In some embodiments, the at least one external antenna comprises a single-turn loop antenna, and the at least one implantable antenna comprises a single-turn loop antenna, and the apparatus operates near an optimal frequency to maximize communication bandwidth.

In some embodiments, the at least one external antenna comprises a loop antenna with a first diameter, and the at least one implantable antenna comprises a loop antenna with a second diameter, and the at least one external antenna is positioned from the at least one implantable antenna at a distance less than approximately one-fifth of the wavelength of the frequency of operation during transmissions of data and/or power between the first external device and the first implantable device. The at least one external antenna can be positioned from the at least one implantable antenna at a distance less than approximately one-twentieth of the wavelength of the frequency of operation during transmissions of data and/or power between the first external device and the first implantable device.

In some embodiments, the apparatus comprises an operating point, and the operating point is optimized based on a Z-parameter matrix. The Z-parameter matrix can be multiple variables that vary due to lateral displacement, rotational displacement, depth displacement, and/or changes in transmission medium, and the optimization is performed over a range in variation of the multiple variables. The optimization, Acan be computed from the Z-parameters and maximized at the frequency of operation and over conditions that define a desired operating range.

In some embodiments, the first implantable device comprises a power harvesting mechanism configured to efficiently recover low voltage signals. The first implantable device can comprise variable loading.

In some embodiments, the apparatus further comprises at least one matching network tuned to improve transmissions between the first external device and the first implantable device. The at least one matching network can be operatively attached to the at least one external antenna and/or the at least one implantable antenna. The at least one matching network comprises a first matching network operatively attached to the at least one external antenna and a second matching network operatively attached to the at least one implantable antenna. The at least one matching network can be selected by evaluating transmissions between the first external device and the first implantable device at a fixed positioned between the two, over a desired operating range, and determining the settings with the highest performance. The at least one matching network can be configured to tune the at least one external antenna and/or the at least one implantable antenna. The at least one matching network can be configured to tune the at least one external antenna.

In some embodiments, the apparatus further comprises a feedback drive configured to provide auditory and/or visual feedback to a user, and the feedback indicates an apparatus condition selected from the group consisting of: first implantable device connectivity status; battery status; communication status between the external system and the implantable system; therapy level; program number; and combinations thereof.

In some embodiments, the apparatus further comprises a detector configured to detect changes to a parameter selected from the group consisting of: impedance of the at least one external antenna; a loading condition; an environmental condition; an interference condition; a fault condition; and combinations thereof. The detector can comprise an RF detector. The detector can provide a signal related to the implant depth of the first implantable device.

In some embodiments, the first implantable device comprises an adjustable load, and adjustments to the load affect the impedance of the at least one external antenna and create a detectable signal in the output power of the first external device.

In some embodiments, the first implantable device is configured to apply and/or adjust a load operatively connected to the at least one implantable antenna to send signals back to the first external device. The load can comprise an impedance between 1 ohm and 100 ohms.

In some embodiments, the first implantable device is configured to provide an open circuit to the at least one implantable antenna to send signals back to the first external device.

In some embodiments, the first external device comprises an accelerometer configured to provide a signal based on the position of the patient, and the apparatus is configured to adjust the stimulation energy delivered to the patient based on the patient position. The apparatus can be configured to debounce the signal provided by the accelerometer.

In some embodiments, the first external device is configured to perform a function selected from the group consisting of: tracking of activity, such as gait and/or sleep as determined by an accelerometer; use of time of day and/or activity patterns to make stimulation adjustments, such as activity patterns determined by an accelerometer; correlation of therapy efficacy with amount of activity; recording of therapy changes associated with an increase and/or decrease in activity; detection of dropping of the first external device, such as to track durability; tracking of the first external device connection state as a function of activity and/or position, such as connectivity state as the patient walks or sleeps; detection of the first external device being disconnected and providing of feedback regarding repositioning of the first external device based on a detected positional change; use of a tapping or shaking motion on the first external device to convey a command; enabling and/or disabling of a control of the first external device with a specific tap gesture; changing of the functionality of a control of the first external device with a specific tap gesture; and combinations thereof.

In some embodiments, the first external device comprises a magnetic sensor configured to produce a signal used to detect the presence of another device.

In some embodiments, the first external device includes a shield comprising a copper shield and a ferrite shield. The shield can be configured to provide a function selected from the group consisting of: reduce deleterious effects of electromagnetic components of the first external device; improve transmissions of the at least one external antenna to the first implantable device; and combinations thereof.

In some embodiments, the first external device comprises a power supply and a housing, and the housing includes a first housing portion that surrounds the power supply, and a second housing portion that surrounds the at least one external antenna.

In some embodiments, the apparatus further comprises a tool for positioning and/or repositioning the first external device on the patient's skin, and the tool includes alignment markings corresponding to multiple positions of placement of the first external device in the tool, each of the positions resulting in sufficient alignment between the at least one external antenna and the at least one implantable antenna to support transmissions between the first external device and the second external device. The tool can comprise at least one replaceable skin attachment patch. The at least one replaceable skin attachment patch can comprise a first area and a second area, and the first area can be attached to the patient's skin for a first time period, and the second area can be attached to the patient's skin for a subsequent, second time period. At least the second area can be covered by a removable liner.

In some embodiments, the first external device comprises an external housing including at least one adhesive patch, and the adhesive patch comprises at least one ring.

In some embodiments, the implantable housing comprises a geometry configured to allow a user to palpate the patient's skin to locate the first implantable device. The apparatus can further comprise a patient attachment device, and the palpation can be used to position the patient attachment device.

In some embodiments, the apparatus further comprises a patient attachment device for securing the first external device to the patient, and the patient attachment device includes a strap and a housing, and the housing is removably attachable to the strap.

In some embodiments, the apparatus further comprises a patient attachment device for securing the first external device to the patient, and the patient attachment device includes a housing with a first portion and a second portion arranged in a clip-like structure.

In some embodiments, the apparatus further comprises a patient attachment device for securing the first external device to the patient, and the patient attachment device includes multiple clips that transition from a first position to a second position to frictionally engage the first external device.

In some embodiments, the apparatus further comprises an implantable lead including the at least one implantable stimulation element, and a lead anchor including a tortuous path for receiving the implantable lead.

In some embodiments, the apparatus further comprises an implantable lead including the at least one implantable stimulation element, and a lead anchor including a housing, a lumen for receiving the implantable lead, and a securing element for frictionally engaging the implantable lead.

In some embodiments, the apparatus further comprises a tool for inserting at least a portion of the first implantable device into the patient, and the tool comprises a first portion for performing blunt tissue dissection to create a tunnel and a subcutaneous pocket, and a second portion for controlling the depth of the tunnel and subcutaneous pocket. The first portion can comprise markings for providing information related to the length of the tunnel being created. The first portion can comprise a first length, and the second portion can comprise a second length greater than the first length, and the second portion can be introduced relatively perpendicular to the patient's skin, and can be subsequently turned relatively parallel to create the tunnel.

In some embodiments, the apparatus further comprises a tool for inserting at least a portion of the first implantable device into the patient, and the tool comprises a handle, a shaft, and a distal end, and the tool further comprises a housing positioned on the distal end and comprising two projections that extend toward a median line of the tool.

In some embodiments, the apparatus further comprises a tool including a clamp and an adaptor, and the clamp includes finger receiving rings, a latching mechanism, two arms, two jaws, and a connecting hinge. The adaptor can comprise a housing with at least two parallel projections.

In some embodiments, the first implantable device comprises an electronic assembly including multiple combined SDSR stages. The electronic assembly can further include a DC-DC conversion stage. The DC-DC conversion stage can comprise an inductive boost converter. The SDSR stages can comprise a first stage, subsequent stages, and capacitive input coupling, and the SDSR stages can rectify power received from the at least one implantable antenna and can multiply the voltage using capacitive input coupling to all but the first stage. The SDSR stages can comprise four stages and while receiving RF amplitudes in the 0.5V to 2V range produces an intermediate DC voltage in the 2V to 4V range. The intermediate DC voltage can be provided to an inductive boost converter. The inductive boost converter can perform further voltage multiplication. The inductive boost converter can output voltage in the 2V to 15V range. The inductive boost converter can provide line and/or load regulation and adjustable output voltage. The inductive boost converter can pass its input to its output without regulation if the voltage commanded by the boost converter is smaller than the input voltage. The intermediate DC voltage can be provided to a buck-boost converter. The electronic assembly may not include a DC-DC conversion stage. The DC output voltage of the SDSR stages can be controlled by the transmissions of the first external device to the first implantable device. The output voltage can be controlled via RF telemetry back to the first external device. The output voltage can be controlled via feedforward control using characterized load data to predict a required RF power. The electronics assembly can comprise an energy storage element in an intermediate stage, the energy storage element can be configured to maintain relatively constant rectifier loading as power is drawn intermittently. Power flow can be adjusted to control the input and output voltages of the SDSR stages at a given loading condition. Power can be controlled by adjusting power levels and/or by performing different forms of power cycling over time. A load impedance can be set to a first order by the DC voltage divided by a constant charging current. An optimal match of the at least one implantable antenna can be chosen to achieve a maximum RF efficiency by powering the first implantable device at a level required to maintain a certain intermediate DC voltage. Flexibility in power and loading can allow the first external device to operate efficiently while operating near an optimal point in the first implantable device.

In some embodiments, the apparatus uses a modulation that doesn't require linearity. The apparatus can use an amplitude modulation with data encoded in a pulse width.

In some embodiments, the apparatus further comprises an amplifier, and the modulation depth is configured to operate in an optimized range of the amplifier to minimize efficiency losses during the transmissions.

In some embodiments, the apparatus is configured to minimize amplitude changes of power transmissions to keep power transfer relatively constant.

In some embodiments, the apparatus can be configured to perform power cycling with adjustable amplitudes of transmissions, and different non-zero levels of power are transferred to the first implantable device. The adjustments to power cycling and/or power transfer amplitude can be based on the apparatus operation and/or apparatus efficiencies. The apparatus efficiencies can comprise efficiencies of a transmitter of the first external device and/or an efficiency of a receiver of the first implantable device.

In some embodiments, efficiencies of the apparatus are monitored and efficiency information is transmitted between the first external device and the first implantable device. The apparatus can be configured to make adjustments to power transfer in real-time and/or at desired intervals.

In some embodiments, the first external device comprises parameters that are sensitive to changes in impedance. The apparatus can be configured to set output power based on the impedance. The impedance can comprise the impedance of the at least one external antenna. The impedance can be changed based on the relative position between the first implantable device and the first external device. The apparatus can be configured to sense a change in output power. The apparatus can be configured to estimate relative position, implantation depth, and/or the link gain to the at least one implantable antenna, based on the sensed change in output power, and to adjust an operating parameter of the first external device. The adjusted operating parameter can comprise a parameter selected from the group consisting of: power output; power cycling; data rate; modulation depth; and combinations thereof.

In some embodiments, the first implantable device comprises an electronic assembly including address-mapped registers. The first implantable device can comprise an electronic assembly including address-mapped registers that are written via the transmissions from the first external device. The first implantable device can comprise a Stimulation Control Table that autonomously generates stimulation pulses and maintains precise stimulation control of timing and amplitude. The registers can comprise one or more parameters selected from the group consisting of: pulse width; inter phase gap; inter pulse interval; and combinations thereof, and the one or more parameters drive the Stimulation Control Table.

In some embodiments, the apparatus comprises loops used to implement stimulation pulse trains and/or stimulation pulse bursts.

In some embodiments, the apparatus comprises a Stimulation Control Table that is configured to implement a 1-level subroutine that minimizes usage of memory of the first implantable device. The subroutine can be configured to deliver complex and/or arbitrary stimulation waveforms.

In some embodiments, the apparatus comprises a Stimulation Control Table and status registers, and the Stimulation Control Table can check the status registers and autonomously takes action as a result. The status registers can comprise contents that are set from comparison between registers and/or measured quantities. The first implantable device can transmit results of the status register checking to the first external device. The first implantable device can halt stimulation if errors are detected in the status register checking.

In some embodiments, the first implantable device comprises one or more tissue anchoring elements. The one or more tissue anchoring elements can comprise an element selected from the group consisting of: a sleeve; a silicone sleeve; a suture tab; a suture eyelet; a bone anchor; wire loops; a porous mesh; a penetrable wing; a penetrable tab; a bone screw eyelet; a tine; pincers; suture slits; and combinations thereof. The one or more tissue anchoring elements can comprise an overmold positioned about at least a portion of the first implantable device.

In some embodiments, the first external device is configured to prevent adversely affecting at least a portion of the patient skin in contact with the first external device. The first external device can be configured to clean and/or promote healing of at least a portion of the patient skin in contact with the first external device. The at least a portion of the first external device can comprise an agent selected from the group consisting of: a bactericidal agent; an anti-fungal agent; and combinations thereof.